YY/T 1651.1-2019 PDF English
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Tests for hemolysis of medical devices - Part 1: Material induced hemolysis assay
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YY/T 1651.1-2019: Tests for hemolysis of medical devices - Part 1: Material induced hemolysis assay
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1651.1-2019
Tests for hemolysis of medical devices - Part 1.Material induced hemolysis assay
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device hemolysis test Part 1.Material mediated
Hemolysis test
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 1651 "Medical Device Hemolysis Test" is divided into the following parts.
--- Part 1.Material-mediated hemolysis test;
--- Part 2.Mechanical force-mediated hemolysis test.
This part is the first part of YY/T 1651.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. Shandong Medical Device Product Quality Inspection Center, Shenzhen Medical Device Testing Center, Chinese Academy of Medical Sciences
Transfusion Research Institute, Shanghai Songli Biotechnology Co., Ltd.
The main drafters of this section. Zhao Zenglin, Hou Li, Cao Ping, Zhong Rui, Li Fangna.
introduction
Hemolysis of medical devices/materials refers to destruction of erythrocyte membranes caused by medical devices/materials or their solubles, free blood in plasma
Increased erythroprotein, resulting in a toxic biological effect. Hemolysis of medical devices/materials is generally divided into material-mediated hemolysis and mechanical
Force-mediated hemolysis in two major categories. Among them, material-mediated hemolysis tests can be divided into direct contact method and indirect contact method. Direct contact method
Is the hemolysis caused by the direct contact of physical and chemical factors with red blood cells on the surface of medical devices/materials. Indirect contact refers to medical devices.
Hemolysis caused by contact of solubles with red blood cells in the device/material. Mechanical force-mediated hemolysis refers to fluid dynamics such as blood
Distortion and rupture of erythrocyte membranes caused by flow rates, eddy currents, and non-physiological shear forces.
The test principles for the blood compatibility of medical devices/materials and the selection strategy for the tests are given in GB/T 16886.4, but the standards are not
Give specific test methods of operation. The absorbance method specified in this section measures hemolysis method and hemoglobin concentration determination hemolysis method. Containing straight
The measurement of contact hemolysis and indirect contact hemolysis is a supplement to GB/T 16886.4.The user should choose according to the intended use of the device.
A suitable method for hemolysis evaluation.
Medical device hemolysis test Part 1.Material mediated
Hemolysis test
1 Scope
This part of YY/T 1651 specifies the absorbance method for hemolysis and the hemoglobin concentration for hemolysis.
This section applies to the evaluation of hemolysis by medical devices/materials.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.2 Biological evaluation of medical devices - Part 2.Animal welfare requirements (GB/T 16886.2-2011,
ISO 10993-2.2006, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4.Selection of test for interaction with blood (GB/T 16886.4-
2003, ISO 10993-4.2002, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials (GB/T 16886.12-
2017, ISO 10993-12..2012, IDT)
3 Terms and definitions
The terms and definitions defined in GB/T 16886.2, GB/T 16886.4, and GB/T 16886.12 apply to this document.
4 blood preparation
In this experiment, the animals were selected as healthy adult rabbits, and the common items were New Zealand white rabbits, which were not limited to males and females. Should comply with GB/T 16886.2
Claim.
About 5 mL of blood was taken from each of the 3 rabbits, collected in an anticoagulation tube and mixed together. At (4 ± 2) °C conditions before use
Under the save, it is recommended to use freshly collected blood within 4 hours. Should be used up within 48h.
Note. Human blood can be selected for testing according to actual needs. Human blood must meet the requirements in accordance with the relevant health, safety and ethical requirements
Eligibility criteria.
5 absorbance determination hemolysis
5.1 Principle of the test
After the test sample or its extract is contacted with fresh anticoagulant, if hemolysis occurs, hemoglobin in the red blood cells is released into the blood.
In the solution, the absorbance of the supernatant was measured after centrifugation, and the negative and positive control absorbance values were measured. By subtracting the negative from the test sample
The hemolysis rate of the test sample was calculated by subtracting the ratio of the positive control from the negative control to evaluate the hemolysis of the test sample.
YY/T 1651.1-2019
Tests for hemolysis of medical devices - Part 1.Material induced hemolysis assay
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device hemolysis test Part 1.Material mediated
Hemolysis test
Testsforhemolysisofmedicaldevices-Part 1.Materialinduced
Hemolysisassay
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 1651 "Medical Device Hemolysis Test" is divided into the following parts.
--- Part 1.Material-mediated hemolysis test;
--- Part 2.Mechanical force-mediated hemolysis test.
This part is the first part of YY/T 1651.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. Shandong Medical Device Product Quality Inspection Center, Shenzhen Medical Device Testing Center, Chinese Academy of Medical Sciences
Transfusion Research Institute, Shanghai Songli Biotechnology Co., Ltd.
The main drafters of this section. Zhao Zenglin, Hou Li, Cao Ping, Zhong Rui, Li Fangna.
introduction
Hemolysis of medical devices/materials refers to destruction of erythrocyte membranes caused by medical devices/materials or their solubles, free blood in plasma
Increased erythroprotein, resulting in a toxic biological effect. Hemolysis of medical devices/materials is generally divided into material-mediated hemolysis and mechanical
Force-mediated hemolysis in two major categories. Among them, material-mediated hemolysis tests can be divided into direct contact method and indirect contact method. Direct contact method
Is the hemolysis caused by the direct contact of physical and chemical factors with red blood cells on the surface of medical devices/materials. Indirect contact refers to medical devices.
Hemolysis caused by contact of solubles with red blood cells in the device/material. Mechanical force-mediated hemolysis refers to fluid dynamics such as blood
Distortion and rupture of erythrocyte membranes caused by flow rates, eddy currents, and non-physiological shear forces.
The test principles for the blood compatibility of medical devices/materials and the selection strategy for the tests are given in GB/T 16886.4, but the standards are not
Give specific test methods of operation. The absorbance method specified in this section measures hemolysis method and hemoglobin concentration determination hemolysis method. Containing straight
The measurement of contact hemolysis and indirect contact hemolysis is a supplement to GB/T 16886.4.The user should choose according to the intended use of the device.
A suitable method for hemolysis evaluation.
Medical device hemolysis test Part 1.Material mediated
Hemolysis test
1 Scope
This part of YY/T 1651 specifies the absorbance method for hemolysis and the hemoglobin concentration for hemolysis.
This section applies to the evaluation of hemolysis by medical devices/materials.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.2 Biological evaluation of medical devices - Part 2.Animal welfare requirements (GB/T 16886.2-2011,
ISO 10993-2.2006, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4.Selection of test for interaction with blood (GB/T 16886.4-
2003, ISO 10993-4.2002, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials (GB/T 16886.12-
2017, ISO 10993-12..2012, IDT)
3 Terms and definitions
The terms and definitions defined in GB/T 16886.2, GB/T 16886.4, and GB/T 16886.12 apply to this document.
4 blood preparation
In this experiment, the animals were selected as healthy adult rabbits, and the common items were New Zealand white rabbits, which were not limited to males and females. Should comply with GB/T 16886.2
Claim.
About 5 mL of blood was taken from each of the 3 rabbits, collected in an anticoagulation tube and mixed together. At (4 ± 2) °C conditions before use
Under the save, it is recommended to use freshly collected blood within 4 hours. Should be used up within 48h.
Note. Human blood can be selected for testing according to actual needs. Human blood must meet the requirements in accordance with the relevant health, safety and ethical requirements
Eligibility criteria.
5 absorbance determination hemolysis
5.1 Principle of the test
After the test sample or its extract is contacted with fresh anticoagulant, if hemolysis occurs, hemoglobin in the red blood cells is released into the blood.
In the solution, the absorbance of the supernatant was measured after centrifugation, and the negative and positive control absorbance values were measured. By subtracting the negative from the test sample
The hemolysis rate of the test sample was calculated by subtracting the ratio of the positive control from the negative control to evaluate the hemolysis of the test sample.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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